Repeated Neurocognitive Measurements in Depressed Patients

NCT05991232 | Withdrawn Phase 1

• 1 other identifier: 2022H0446
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, we will A) track the functioning of a collection of potential neurobiological targets for depression over time, B) examine how fluctuations in the functioning of those targets relates to real-world functioning, and C) in a subset of the sample, determine how the functioning in those targets is altered by a single dose of ketamine.

Conditions

Depression, Unipolar

Keywords

Depressive Disorder; Mood Disorders; Mental Disorders; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action

Outcome Measures

Primary Outcomes (1)

• fMRI resting state connectivity

  directed connectivity beta weights between default mode, frontoparietal, limbic/affective, and salience networks (larger beta weight = stronger connectivity)

  24hrs post-intervention

Secondary Outcomes (9)

• Montgomery-Asberg Depression Rating Scale

  24hrs post-intervention

• Montgomery-Asberg Depression Rating Scale

  5 days post-intervention

• Montgomery-Asberg Depression Rating Scale

  12 days post-intervention

• Hamilton Depression Rating Scale

  24hrs post-intervention

• Hamilton Depression Rating Scale

  5 days post-intervention

Study Arms (1)

Intravenous Ketamine

EXPERIMENTAL

Open-label ketamine infusion

Drug: Intravenous Ketamine

Interventions

Intravenous Ketamine DRUG

Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)

Also known as: Ketalar

Intravenous Ketamine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All participants will:
• be between the ages of 18 and 60 years,
• score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D)
• possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document

You may not qualify if:

• All participants:
• Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
• Changes made to treatment regimen within 4 weeks of baseline assessment.
• Reading level \<6th grade as per patient self-report.
• Patients who have received ECT in the past 2 months prior to Screening.
• Patients currently taking any psychotropic medication.
• Lifetime recreational ketamine or PCP use
• Current pregnancy or breastfeeding
• Clinically significant abnormal findings of laboratory parameters \[including urine toxicology screen for drugs of abuse\], physical examination, or ECG.
• Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.
• Patients with one or more seizures without a clear and resolved etiology.
• Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.
• Past intolerance or hypersensitivity to ketamine.
• Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[e.g., riluzole, amantadine, memantine, topiramate, dextromethorphan, Dcycloserine\], or the mu-opioid receptor.
• Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.

Sponsors & Collaborators

• Jay Fournier: lead

Study Sites (1)

The Ohio State University, Department of Psychiatry & Behavioral Health

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Mood Disorders; Mental Disorders

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry & Behavioral Health

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 14, 2023
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)